Quality Engineer - CAPA (Freelance)

Responsible for driving CAPA activities from issue identification to closure, effectively project managing all CAPA activities, ensuring
the quality of CAPA record content and representing CAPAs during audits and CAPA Review Board meetings.

Description

• Facilitate product and process Corrective and Preventive Action (CAPA)  investigations from issue identification through implementation of  solution and effectiveness monitoring.
• Project manage all aspects of CAPA activity which includes gaining the commitment of cross functional resources, scheduling CAPA team meetings, and ensuring CAPA deliverables per project timelines.
• Represent CAPAs during audits and CAPA Review Board meetings.
• Lead and mentor cross functional teams with the implementation of appropriate root cause analysis techniques (e.g. Pride problem solving).
• Analyze quality monitoring data sources and apply statistical techniques to identify existing and potential causes of non-conformances.
• Work effectively with all levels of management to ensure CAPA action plans can be supported and that costs/resources needed to implement the plan are available.
  
  Requirements 
  - Bachelor's degree in an engineering or scientific discipline, or equivalent experience
  - Working knowledge of appropriate global medical device regulations and standards
  - 3+ years experience in a regulated industry (medical device, IVD)
  - 3+ year working in the area of quality management systems and/or regulatory affairs
  - Experience in CAPA management and problem solving
  - Strong personal skills demonstrating structured and self-organized way of working
  - Ability to communicate effectively both orally and in writing with subject matter experts and other functional areas.
  - Strong analytical and process focused thinking skills
  - Ability to work in a virtual team and within a cross functional global organization
  - Demonstrate Philips behaviors
  - Flexible